While there are 37 known confirmed cases of infant botulism linked to ByHeart infant formula in the United States, it is not yet known whether there are cases in any of the 21 other countries that received the formula.
As of the most recent report from the U.S. Food and Drug Administration on Nov. 26, a total of 37 infants with infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula have been reported from 17 states. For 36 cases with illness onset information available, illnesses started on dates ranging from Aug. 9 to Nov. 19, 2025. All 37 infants were hospitalized. No deaths have been reported to date.
ByHeart has recalled all of its powdered infant formula. Botulism has been found in unopened cans of the formula.
Treatment in the United States consists of supportive care and the use of BabyBIG (Botulism Immune Globulin Intravenous), which is an FDA-approved, human-derived antibody treatment for infant botulism types A and B. By providing antibodies against the botulism toxin, BabyBIG can significantly shorten the length and reduce the severity of the illness, leading to shorter hospital stays and lower costs
According to the Infant Botulism Treatment and Prevention Program (IBTPP), BabyBIG is not available through standard channels like pharmacies. It is only available through the IBTPP, which is run by the California Department of Public Health. A treating physician must contact the IBTPP’s on-call physicians for a clinical consultation and to initiate the process for obtaining the medication.
The U.S. Food and Drug Administration reports that ByHeart’s recalled infant formula was distributed to Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand and the British Virgin Islands.
According to recent journal article, Human Botulism Immune Globulin Intravenous (BIG-IV) was licensed in the United States in October 2003 for the treatment of the rare, life-threatening infectious disease, infant botulism (IB) from botulinum toxin types A or B. International use of BIG-IV began in July 2005 on a case-by-case basis following approval by the respective countries’ medicines regulatory agencies authorizing its importation. Since 2005, BIG-IV has been distributed to 16 countries on five continents.
Treatment of international patients was more likely to be delayed until laboratory confirmation was obtained. Longer time to BIG-IV infusion likely contributed to longer hospital stays in international patients. Time to infusion differences could also be attributed to process delays in obtaining required approvals to import given BIG-IV is not licensed outside the U.S., transport challenges related to distance and customs clearance delays.
